Adjuvant Acupuncture Care for Breast Cancer Patients Expe... | NCT00885183

Studies
Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy

NCT00885183

Sponsor

University Hospital of North Norway

Status

Terminated

Last Update Posted

Jul 1, 2019Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Acupuncture therapy

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficult to recruit participants

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2013Actual

Completion Date

Jun 2014Actual

First Submitted Date

Apr 19, 2009

First Submission Date that Met QC Criteria

Apr 20, 2009

First Posted Date

Apr 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2019

Last Update Posted Date

Jul 1, 2019Actual

Name	Class
Norwegian Cancer Society	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Breast cancer patients report many symptoms while undergoing conventional care, including nausea/vomiting, fatigue, pain, depression and anxiety. Existing interventions to address these common side effects of treatment are limited. Patients diagnosed with cancer frequently seek complementary medicine (CAM), and there is a need to investigate potential effects of CAM therapies. This phased pilot and feasibility study has two aims:

Develop an acupuncture treatment protocol for adjuvant acupuncture care for breast cancer patients undergoing chemotherapy using structured interviews with established acupuncture teams in Norway.
Implement the treatment protocol in a pilot study to evaluate outcome measures, effect sizes and acceptability of acupuncture care delivered alongside conventional care.

Study results will support the design of future research; including a Phase III randomised controlled trial.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
acupuncture therapy	Experimental	Breast cancer patients are randomised to additional 12 acupuncture treatment sessions while undergoing standard chemotherapy	Procedure: Acupuncture therapy
Usual care	Other	Control group (usual care) receives standard chemotherapy alone	Procedure: Acupuncture therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture therapy	Procedure	12 acupuncture treatment sessions for a period of 16 weeks	Usual care acupuncture therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fatigue scale		Weeks 16 and 29

Secondary Outcomes

Measure	Description	Time Frame
Health related quality of life: EORTC QLQ-C30, EORTC QLQ-BR23, MYCaw		Weeks 16, 19 and 29
Hospital anxiety and depression scale (HADS)		Weeks 16, 19 and 29

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females, 18 years or older with early stage breast cancer, no previous chemotherapy and no metastatic disease

Exclusion Criteria:

Needle phobia, use of anticoagulant drugs, inability to comply with study regimen

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sameline Grimsgaard, MD, MPH, PhD	Clinical Research Centre, University Hospital of North Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of North Norway		Tromsø		No-9038	Norway

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D005221	Fatigue

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015670	Acupuncture Therapy

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided